Clinical Bioanalyst - Oncology Drug Development

Immunome, Inc.; Bothell (WA); On-site; USD 120,000 - 142,000; Full time

Job summary

Immunome, Inc. in Washington state is seeking a Bioanalyst to develop and implement bioanalytical assays supporting clinical-stage bioanalysis for oncology programs. You will design, develop, and execute bioanalytical strategies across multiple candidates under supervision.

Key responsibilities include overseeing CROs, collaborating across functions, and authoring study protocols, analysis plans, and regulatory submissions to advance programs through development.

Qualifications

• Minimum 5 years in a regulated bioanalytical environment, preferably across modalities.
• 3+ years managing relationships with global bioanalytical vendors (CROs).
• Familiarity with GLP, GCLP, ICH M10 and regulatory guidance.
• Hands-on experience with method development, validation, and troubleshooting.

Responsibilities

• Develop and implement bioanalytical assays for compounds in clinical development.
• Oversee CROs performing bioanalytical work and ensure regulatory compliance.
• Partner with other functions to progress programs through development.
• Author sections of protocols, plans, reports, and regulatory submissions.

Skills

Bioanalytical assay development

CRO/vendor management

LC-MS/MS

Regulatory submissions

Tools

LC-MS/MS

Job description

Immunome, Inc. in Washington state is seeking a Bioanalyst to develop and implement bioanalytical assays supporting clinical-stage bioanalysis for oncology programs. You will design, develop, and execute bioanalytical strategies across multiple candidates under supervision.

Key responsibilities include overseeing CROs, collaborating across functions, and authoring study protocols, analysis plans, and regulatory submissions to advance programs through development.